Search results for "quality" in Articles / App Notes
Article
Establishment of New Modern Plasma Fractionation Facilities in Asia
…ties, all of which utilize modern chromatographic processes to produce plasma products of very high quality and safety. It is not inconceivable that over the next decade China will become a major pla…
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Making the Move to Continuous Chromatography
…chromatography can also give additional process robustness and control and lead to improved product quality levels, which can be particularly useful when processing unstable molecules.
Access …
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What's in Your SOP?
SOPs document the steps of key processes to help ensure a consistent, quality output. SOPs are useful tools for operationalizing, optimizing, and communicating important corporate policies, government…
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Transformative Medicines Challenge FDA and Manufacturers
At a conference in October 2017 on oligonucleotide-based therapeutics sponsored by FDA and the Drug Information Association (DIA), experts explored strategies for tackling quality risk management, set…
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Downstream Processing for Cell-Based Therapies
As such, manufacturing processes need to be adapted to ensure that the cellular material retains its functionality and the critical quality attributes (CQAs) are maintained throughout the entire proce…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
“Biosimilars are constrained in that they have to hit certain quality parameters set by the innovator,” Elhofy says. Essential Pharmaceuticals provides an animal-component free media that boosts titer…
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Evaluating E&L Studies for Single-Use Systems
Regulatory guidelines require that the product contact items “shall not be reactive, additive, or absorptive” to assure drug product quality and safety (2). The manufacturer is, therefore, responsible…
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Defining Risk Assessment of Aseptic Processes
Schniepp
Q: I work in the quality group for a manufacturer who makes intravenous (IV) injectable drugs using aseptic processing techniques. Recently, the facility has experienced an increase in the…
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Generating a Fully Processed Antibody
Producing these multisubunit molecules or processing proteins in the correct proportions to obtain maximum titer and biopharmaceutical quality can be difficult using traditional cell-line development …
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Continuous Processing for the Production of Biopharmaceuticals
The key drivers for this evolution include rising demand, the desire for reduced processing costs, more stringent requirements for consistent quality, and most importantly, the requirement for higher …